EP3427054A4 - Immunoassay controls and the use thereof - Google Patents

Immunoassay controls and the use thereof Download PDF

Info

Publication number
EP3427054A4
EP3427054A4 EP17763934.1A EP17763934A EP3427054A4 EP 3427054 A4 EP3427054 A4 EP 3427054A4 EP 17763934 A EP17763934 A EP 17763934A EP 3427054 A4 EP3427054 A4 EP 3427054A4
Authority
EP
European Patent Office
Prior art keywords
immunoassay
controls
immunoassay controls
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP17763934.1A
Other languages
German (de)
French (fr)
Other versions
EP3427054A2 (en
Inventor
Jonathan Gary
Scott Rongey
James Powell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Quidel Cardiovascular Inc
Original Assignee
Quidel Cardiovascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Quidel Cardiovascular Inc filed Critical Quidel Cardiovascular Inc
Publication of EP3427054A2 publication Critical patent/EP3427054A2/en
Publication of EP3427054A4 publication Critical patent/EP3427054A4/en
Pending legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54393Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K7/00Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04Linear peptides containing only normal peptide links
    • C07K7/06Linear peptides containing only normal peptide links having 5 to 11 amino acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K7/00Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04Linear peptides containing only normal peptide links
    • C07K7/08Linear peptides containing only normal peptide links having 12 to 20 amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/4712Muscle proteins, e.g. myosin, actin, protein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2410/00Assays, e.g. immunoassays or enzyme assays, involving peptides of less than 20 animo acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6887Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from muscle, cartilage or connective tissue
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
EP17763934.1A 2016-03-07 2017-03-07 Immunoassay controls and the use thereof Pending EP3427054A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662304762P 2016-03-07 2016-03-07
US201662346347P 2016-06-06 2016-06-06
PCT/US2017/021211 WO2017156038A2 (en) 2016-03-07 2017-03-07 Immunoassay controls and the use thereof

Publications (2)

Publication Number Publication Date
EP3427054A2 EP3427054A2 (en) 2019-01-16
EP3427054A4 true EP3427054A4 (en) 2019-12-04

Family

ID=59789799

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17763934.1A Pending EP3427054A4 (en) 2016-03-07 2017-03-07 Immunoassay controls and the use thereof

Country Status (6)

Country Link
US (3) US11237163B2 (en)
EP (1) EP3427054A4 (en)
JP (1) JP6995768B2 (en)
CN (1) CN109154602B (en)
AU (1) AU2017229495C1 (en)
WO (1) WO2017156038A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3427054A4 (en) 2016-03-07 2019-12-04 Quidel Cardiovascular Inc. Immunoassay controls and the use thereof
WO2023279073A1 (en) * 2021-07-01 2023-01-05 Amicus Therapeutics, Inc. Neurotensin variants and tagged proteins comprising neurotensin or sortilin propeptide

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002077646A1 (en) * 2001-03-26 2002-10-03 Response Biomedical Corporation Compensation for variability in specific binding in quantitative assays
US6475785B1 (en) * 1997-12-18 2002-11-05 Spectral Diagnostics, Inc. Single-chain polypeptides comprising troponin I N-terminal fragments and troponin C
WO2015143394A1 (en) * 2014-03-20 2015-09-24 Bio-Rad Laboratories, Inc. Glycated protein assay
US20150293086A1 (en) * 2014-04-14 2015-10-15 Abreos Biosciences, Inc. Lateral flow immunoassay

Family Cites Families (15)

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Publication number Priority date Publication date Assignee Title
EP1248112A3 (en) * 1987-04-27 2004-08-25 Inverness Medical Switzerland GmbH Immunochromatographic specific binding assay device
IL85899A0 (en) * 1987-06-10 1988-09-30 Miles Inc Method,test device and test kit for separating labeled reagent in an immunometric binding assay
EP0820466A2 (en) * 1995-04-04 1998-01-28 Advanced Bioconcept Inc. Fluorescent peptides
DE69624920T2 (en) * 1996-09-27 2003-09-18 Inverness Medical Switzerland Test reagents and test devices
BR9909044A (en) * 1998-03-24 2000-12-05 Aventis Pharma Sa Nucleic acid transfer vector, composition, use of a nucleic acid transfer vector, processes of transfection of nucleic acids in cells, and treatment of diseases, and, recombinant cell
US7175953B2 (en) * 1999-04-09 2007-02-13 Institute Fuer Diagnostik Forschung Short-warp peptide-dye conjugate as contrast agent for optical diagnostic
US20030105299A1 (en) * 2001-10-17 2003-06-05 Mallinckrodt Inc. Carbocyanine dyes for tandem, photodiagnostic and therapeutic applications
US7239394B2 (en) * 2003-06-04 2007-07-03 Inverness Medical Switzerland Gmbh Early determination of assay results
US7634360B2 (en) * 2003-09-23 2009-12-15 Prediction Sciences, LL Cellular fibronectin as a diagnostic marker in stroke and methods of use thereof
GB2433989B (en) * 2004-07-01 2009-04-08 Central Science Lab Analyte detection system
WO2006065967A2 (en) * 2004-12-15 2006-06-22 General Atomics Allosteric enzyme coupled immunoassay (aecia)
RU2007137263A (en) * 2005-03-09 2009-04-20 Борд Оф Риджентс, Дзе Юниверсити Оф Техас Систем (Us) WAYS AND COMPOSITION RELATING TO VISUALIZING EXPRESSION OF A GEN VIVO GENE
CN102128934A (en) * 2010-01-13 2011-07-20 贵州省临床检验中心 Method for detecting human myocardial troponin T through cytometric bead array
US9551714B2 (en) * 2010-06-25 2017-01-24 Abbott Laboratories Materials and methods for assay of anti-hepatitis C virus (HCV) antibodies
EP3427054A4 (en) 2016-03-07 2019-12-04 Quidel Cardiovascular Inc. Immunoassay controls and the use thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6475785B1 (en) * 1997-12-18 2002-11-05 Spectral Diagnostics, Inc. Single-chain polypeptides comprising troponin I N-terminal fragments and troponin C
WO2002077646A1 (en) * 2001-03-26 2002-10-03 Response Biomedical Corporation Compensation for variability in specific binding in quantitative assays
WO2015143394A1 (en) * 2014-03-20 2015-09-24 Bio-Rad Laboratories, Inc. Glycated protein assay
US20150293086A1 (en) * 2014-04-14 2015-10-15 Abreos Biosciences, Inc. Lateral flow immunoassay

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HOLTOM P.E. ET AL.: "A highly sensitive and selective radioimmunoassay for the measurement of neurotensin", J. NEUROSCI. METH., vol. 100, no. 1-2, July 2000 (2000-07-01), pages 151 - 156, XP055630347 *

Also Published As

Publication number Publication date
AU2017229495B2 (en) 2020-02-06
CN109154602B (en) 2022-04-15
JP2019510219A (en) 2019-04-11
US11726085B2 (en) 2023-08-15
JP6995768B2 (en) 2022-02-21
US20240003874A1 (en) 2024-01-04
AU2017229495A1 (en) 2018-09-27
CN109154602A (en) 2019-01-04
US20220107314A1 (en) 2022-04-07
US11237163B2 (en) 2022-02-01
WO2017156038A2 (en) 2017-09-14
WO2017156038A3 (en) 2017-10-05
US20190339264A1 (en) 2019-11-07
AU2017229495C1 (en) 2020-05-14
EP3427054A2 (en) 2019-01-16

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